A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight

EyeQue

Status: Completed

Conditions: Myopia

Treatments: Device: Visual Acuity with a Hand-held Device Supported by Mobile App.

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04693260

EYEQUE - 007

Details and patient eligibility

About

The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Full description

A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.

Enrollment: 32 patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or Female
2. Ages =>7 y.o.
3. Subjects that are minors (<18 years old) must have a parent or legal guardian.
4. Binocular vision
5. Willing and able to give informed consent and follow all study procedures and requirements
6. Fluent in English
7. Be treated for myopia with Ortho-K, day contacts, or night contacts

Exclusion criteria

1. Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.

2. Has traveled outside the country within the last 4 weeks

3. Medications:

   a. Taking medications that may affect ability to follow instructions.

4. Eye Disease:

   a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection, keratoconus, etc.

5. Subjects that:

   1. Lack physical dexterity to properly operate the EyeQue App on the smartphone
   2. Lack the ability to follow instruction
   3. Lack binocular vision
   4. Lack the ability to maintain both eyes open
   5. Had eye surgery within the last 12 months (including Lasik)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Hand-held Device Supported by Mobile Application

Other group

Description:

Insight device ETDRS measurement compared to a standard ETDRS chart

Treatment:

Device: Visual Acuity with a Hand-held Device Supported by Mobile App.